Gemogenovatucel-T (Vigil) immunotherapy demonstrates clinical benefit in homologous recombination proficient (HRP) ovarian cancer.

Autor: Rocconi RP; University of South Alabama - Mitchell Cancer Institute, Mobile, AL, United States of America., Monk BJ; Arizona Oncology, Phoenix, AZ, United States of America., Walter A; ProMedica, Toledo, OH, United States of America., Herzog TJ; University of Cincinnati Cancer Center, Cincinnati, OH, United States of America., Galanis E; Mayo Clinic, Rochester, MN, United States of America., Manning L; Gradalis, Inc., Carrollton, TX, United States of America., Bognar E; Gradalis, Inc., Carrollton, TX, United States of America., Wallraven G; Gradalis, Inc., Carrollton, TX, United States of America., Stanbery L; Gradalis, Inc., Carrollton, TX, United States of America., Aaron P; Gradalis, Inc., Carrollton, TX, United States of America., Senzer N; Gradalis, Inc., Carrollton, TX, United States of America., Coleman RL; US Oncology Research, The Woodlands, TX, United States of America., Nemunaitis J; Gradalis, Inc., Carrollton, TX, United States of America. Electronic address: jnemunaitis@gradalisinc.com.
Jazyk: angličtina
Zdroj: Gynecologic oncology [Gynecol Oncol] 2021 Jun; Vol. 161 (3), pp. 676-680. Date of Electronic Publication: 2021 Mar 11.
DOI: 10.1016/j.ygyno.2021.03.009
Abstrakt: Objective: Recently, Vigil showed significant clinical benefit with improvement in relapse free (RFS) and overall survival (OS) in pre-planned subgroup analysis in stage III/IV newly diagnosed ovarian cancer patients with BRCA wild type (BRCA-wt) molecular profile. Here we analyze homologous recombination (HR) status of patients enrolled in the Phase 2b VITAL study and determine clinical benefit of Vigil in HR proficient (P) patients.
Methods: Patients were previously enrolled in a Phase 2b, double-blind, placebo-controlled trial. All were in complete response with Stage III/IV high grade serious, endometroid or clear cell ovarian cancer. HR status was determined using MyChoice®CDx score (<42 = HRP) (Myriad Genetics, Inc., UT). Post-hoc analyses were carried out using Kaplan Meier and restricted mean survival time (RMST) analysis to evaluate RFS and OS based on HR deficiency (D) status.
Results: RFS was improved with Vigil (n = 25) in HRP patients compared to placebo (n = 20) (HR = 0.386; 90% CI 0.199-0.750; p = 0.007), results were verified by RMST (p = 0.017). Similarly, OS benefit was observed in Vigil group compared to placebo (HR = 0.342; 90% CI 0.141-0.832; p = 0.019). Results with OS were also verified with RMST (p = 0.008).
Conclusion: Vigil exhibited clinical benefit in HRP molecular profile patients.
Competing Interests: Declaration of Competing Interest RPR reports sponsored research related to this work. BJM reports personal fees from Abbvie, Advaxis, Agenus, Amgen, Aravive, AstraZeneca, Asymmetric Therapeutics, Boston Biomedical, ChemoCare, ChemoID, Circulogene, Clovis, Conjupro, Easai, Geistlich, Genmab/Seattle Genetics, GOG Foundation, Gradalis, ImmunoGen, Immunomedics, Incyte, Janssen/ Johnson & Johnson, Laekna Health Care, Mateon (formally Oxigene), Merck, Mersana, Myriad, Nucana, Oncomed, Oncoquest, Oncosec, Perthera, Pfizer, Precision Oncology, Puma, Regeneron, Roche/ Genentech, Samumed, Takeda, Tesaro/GSK, VBL, and Vigeo, outside the submitted work. EG reports personal fees or grant funding from MedImmune, Gradalis, Agios Pharmaceuticals, Karyopharm, Tracon, Genentech, Bristol Myers Squibb, outside the submitted work. All other authors declare no competing interests.
(Copyright © 2021. Published by Elsevier Inc.)
Databáze: MEDLINE
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